FDA EIR - Sharp Packaging Services, LLC - April 24, 2019

An FDA inspection of Sharp Corporation, a contract human and veterinary drug packager located in Allentown, PA, was conducted from April 23-24, 2019. This "for cause" inspection, carried out under Compliance Program 7356.002B (Drug Repackers and Relabelers), focused on packaging operations for a human drug product. The inspection revealed a significant deficiency, leading to the issuance of a one-item Form FDA-483. The main violation cited Sharp Corporation for its failure to maintain adequate documentation of incoming visual inspections for bulk product, specifically the visual integrity inspection of foil bags containing bulk film, a required step per packaging component specifications (21 CFR 211.184(b)). The company's component records lacked the necessary test results and conclusions for these inspections. Additionally, a discussion item highlighted an issue with in-process testing, noting the firm's failure to collect representative samples for verifying the seal of drug pouches across all production lanes, despite evidence of uneven wear on sealing plates. Management acknowledged both findings during the close-out meeting and committed to implementing the necessary corrections to ensure compliance with regulatory standards.